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Trial registered on ANZCTR


Registration number
ACTRN12611001120965
Ethics application status
Approved
Date submitted
15/09/2011
Date registered
26/10/2011
Date last updated
19/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Internet-based treatment of Panic Disorder and/or agoraphobia (the revised Panic program): A randomised controlled study exploring the role of a clinician.
Scientific title
A randomised controlled trial comparing clinician-assisted Internet based treatment for panic disorder with or without agoraphobia vs. a waitlist control on severity of symptoms of panic.
Secondary ID [1] 263045 0
Nil
Universal Trial Number (UTN)
Trial acronym
Panic - A Randomised Controlled Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Panic Disorder with or without Agoraphobia 270778 0
Condition category
Condition code
Mental Health 270962 270962 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly assigned to one of two groups: 1) Treatment with clinician-assisted Internet based treatment for panic, or; 2) Waitlist control. Treatment will be completed individually via the internet based CBT course (ie not as part of a group), and any clinician (Psychiatrist) assistance will be one-on-one. All participants will meet Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV) criteria for Panic Disorder with or without Agoraphobia. All group 1 participants will complete 5 lessons of Internet based treatment about the management of symptoms of panic. One lesson will be completed every 7 to 14 days (patients can move through to the next lesson every 7 days, however, the lesson will be available for up to 14 days). Each lesson will take about 15 minutes to complete. Group 1 participants will have access to summaries of each lesson, homework exercises, and will receive weekly reminder emails. Contact with the clinician (a Psychiatrist) will be as and when required, and contact content will vary based on the demands of individual patients. The duration of the program is 8 weeks, but participants will be contacted 3 months post program and asked to complete follow-up questionnaires. Study questionnaires will be administered at application, pre-treatment, mid-treatment, post-treatment, and 3 months post-treatment. These will take about 20 minutes to complete. The treatment materials are based on cognitive behavioural techniques.
Intervention code [1] 269390 0
Treatment: Other
Intervention code [2] 283621 0
Behaviour
Comparator / control treatment
Waitlist control group. These participants remain on the waitlist until the treatment groups have completed their treatment (8 weeks). At that time (8 weeks) the waitlist group will receive the same treatment as Treatment Group 1.
Control group
Active

Outcomes
Primary outcome [1] 279628 0
Symptoms and severity of panic is measured by the Panic Disorder Severity Scale (PDSS-SR).
Timepoint [1] 279628 0
Administered at application, pre-treatment, mid-treatment, post-treatment, and at 3 months post-treatment.
Secondary outcome [1] 294088 0
Psychological distress is measured by the Kessler-10 (K-10).
Timepoint [1] 294088 0
Administered before each lesson, at pre-treatment, mid-treatment, post-treatment, and at 3 months post-treatment.
Secondary outcome [2] 294089 0
Symptoms and severity of depression is measured by the Patient Health Questionnaire-9 (PHQ-9).
Timepoint [2] 294089 0
Administered at at application, pre-treatment and post-treatment.
Secondary outcome [3] 294090 0
Temperament is measured by the NEO-Five Factor Inventory, Neuroticism scale (NEO-FF-I, N scale).
Timepoint [3] 294090 0
Administered at pre-treatment and post-treatment.
Secondary outcome [4] 294091 0
Disability is measured by the WHO Disability Assessment Scale (WHODAS-II).
Timepoint [4] 294091 0
Administered at pre-treatment and post-treatment.
Secondary outcome [5] 294092 0
Acceptability to patients (Patient Satisfaction Scale, appended).
Timepoint [5] 294092 0
Administered at pre-treatment and post-treatment.

Eligibility
Key inclusion criteria
Meet Diagnostic and Statistical Manual of the American Psychiatric Association-4th Edition (DSM-IV) criteria for Panic Disorder and/or Agoraphobia, Internet access, printer access, Australian citizen.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current substance abuse/dependence, Psychotic mental illness (Bipolar or Schizophrenia), Current or planned psychological treatment during study duration, Change in medications during last 1 month or intended change during study duration, Suicidal.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants apply on line, followed by a telephone interview to confirm diagnosis via the Mini-International Neuropsychiatric Interview (MINI 5.0.0), a structured diagnostic interview. Participants will be randomized using a list generated prior to the study. Allocation concealment will occur in the following way: A staff member not involved in the clinical trial will generate the sequence using computer software, and place each choice in a sequentially numbered, opaque, sealed and stapled envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomisation list will be generated prior to the study using computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/11/2011
Actual
15/11/2011
Date of last participant enrolment
Anticipated
15/10/2013
Actual
15/10/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
68
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 269857 0
Hospital
Name [1] 269857 0
St Vincent's Hospital, Sydney
Country [1] 269857 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital, Sydney
Address
390 Victoria St
Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 268880 0
None
Name [1] 268880 0
Address [1] 268880 0
Country [1] 268880 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271829 0
St Vincent's Hospital Human Research Ethics Committee (HREC)
Ethics committee address [1] 271829 0
St Vincent's Hospital HREC
390 Victoria Street
Darlinghurst NSW 2010
Ethics committee country [1] 271829 0
Australia
Date submitted for ethics approval [1] 271829 0
Approval date [1] 271829 0
07/04/2008
Ethics approval number [1] 271829 0
08/HREC/36

Summary
Brief summary
Our previous research indicates that the Panic Program, an Internet-based treatment program for people with Panic Disorder with or without Agoraphobia is effective at helping people to learn to manage their symptoms of panic.

The study described here aims to find out whether therapist support is required for people to successfully complete the Panic Program.

We expect that people completing the Panic Program without therapist support (but who receive weekly telephone reminders) will still benefit, but not as much as those receiving the usual levels of therapist support.
Trial website
www.virtualclinic.org.au
Trial related presentations / publications
BJPsych Open (in press)
Public notes

Contacts
Principal investigator
Name 33160 0
Prof Professor Gavin Andrews
Address 33160 0
St Vincent's Hospital, Sydney 390 Victoria St Darlinghurst NSW 2010
Country 33160 0
Australia
Phone 33160 0
+612 8382 1400
Fax 33160 0
Email 33160 0
[email protected]
Contact person for public queries
Name 16407 0
Professor Gavin Andrews
Address 16407 0
St Vincent's Hospital, Sydney
390 Victoria St
Darlinghurst NSW 2010
Country 16407 0
Australia
Phone 16407 0
+612 8382 1400
Fax 16407 0
+612 8382 1401
Email 16407 0
[email protected]
Contact person for scientific queries
Name 7335 0
Professor Gavin Andrews
Address 7335 0
St Vincent's Hospital, Sydney
390 Victoria St
Darlinghurst NSW 2010
Country 7335 0
Australia
Phone 7335 0
+612 8382 1400
Fax 7335 0
+612 8382 1401
Email 7335 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.